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FDA REPRIMANDS LEXIS FOR "FALSE AND MISLEADING" N.E.E. 1/35 PRESS RELEASE; FDA AD REVIEW IS NOT "ENCOURAGEMENT" OF DIRECT-TO-CONSUMER AD CAMPAIGNS

Executive Summary

Lexis Pharmaceuticals' press release announcing the launch of a new generic oral contraceptive, N.E.E. 1/35, overstated FDA's position on direct-to-consumer ads and mistakenly took credit for running the first such ads, FDA told the company in a recent regulatory letter. Specifically, the Lexis press release cited FDA's pre-launch review of Lexis' direct-to-consumer ad campaign as agency "encouragement" of the principle. "Generally, we believe that the press release has resulted in the communication of false and/or misleading concepts concerning FDA's participation in this manner," FDA said in the Feb. 8 reg letter. "We believe the press release exaggerates this effort and has misleadingly suggested that FDA 'encourages' direct to consumer advertising of prescription drugs." FDA said its position is to "neither discourage or encourage direct-to-consumer advertising of prescription drugs." The FDA ad division's "active role in providing comments, suggestions and/or other forms of guidance at your request was neither any more or less than we would provide any sponsor of pharmaceutical advertising embarking in a new area," the correspondence adds. Lexis' February launch of N.E.E. 1/35 (norethindrone/ethinyl estradiol) marked the firm's first entry into the generic oral contraceptive market. The launch included price comparison print ads in women's magazines as well as a rebate program ("The Pink Sheet" Feb. 13, T&G-1). FDA also called Lexis to task on two other aspects of the press release. The Lexis press release called the company's ad campaign the "first-ever consumer ads for prescription drugs." FDA pointed out that direct-to-consumer advertising of prescription drugs "has been around, although sporadic, prior to 1983." FDA also objected to the absence of either "full disclosure" information or product labeling accompanying the press release.

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